A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa

A Phase 3, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa (Protocol No.:INCB 54707-312)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051240088

Enrollment

Registered

2024-07-12

Start date

2024-09-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hidradenitis Suppurativa

Interventions

Experimental: Cohort A Povorcitinib at the protocol-defined dose strength based on cohort assignment. Experimental: Cohort B Povorcitinib at the protocol-defined dose strength based on cohort assignme

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Completion of the study treatment period of the originating parent study (INCB 54707-301 or INCB 54707-302). 2. Agreement to use contraception. 3. Willing and able to comply with the study protocol and procedures. 4. Further inclusion criteria apply.

Exclusion criteria

Exclusion criteria: 1. Participation in the extension study could expose the participant to an undue safety risk. 2. Women who are pregnant (or who are considering pregnancy) or breastfeeding. 3. Further exclusion criteria apply.

Design outcomes

Primary

Measure	Time frame
Proportion of participants with Treatment-Emergent Adverse Events (TEAEs) [Time Frame: up to approximately 56 weeks]	—

Secondary

Measure	Time frame
1. Proportion of participants with Serious Treatment-Emergent Adverse Events (TEAEs) [Time Frame: up to approximately 56 weeks] 2. Proportion of participants with TEAEs leading to study drug discontinuation [Time Frame: up to approximately 56 weeks] 3. Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR) [Time Frame: up to approximately 56 weeks] 4. Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) [Time Frame: up to approximately 56 weeks] 5. Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) [Time Frame: up to approximately 56 weeks] 6. Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 100 (HiSCR100) [Time Frame: up to approximately 56 weeks] 7. Proportion of participants with flare at each visit [Time Frame: up to approximately 56 weeks] 8. Time to first flare [Time Frame: up to approximately 56 weeks] 9. Mean change from baseline of parent study in Hidradenitis Suppurativa Quality of Life (HiSQoL) score at each visit [Time Frame: up to approximately 56 weeks] 10. Mean change from baseline of parent study in Dermatology Life Quality Index (DLQI) score at each visit [Time Frame: up to approximately 56 weeks] 11. Proportion of participants with no increase in abscess and inflammatory nodule (AN) count relative to Week 54 at each visit [Time Frame: up to approximately 56 weeks] 12. Proportion of participants with no increase in abscess, inflammatory nodule, and draining tunnel (ANdT) count relative to Week 54 at each visit [Time Frame: up to approximately 56 weeks] 13. Proportion of participants with no increase in draining tunnel count relative to Week 54 at each visit [Time Frame: up to approximately 56 weeks] 14. Proportion of participants with a total AN count of 0, 1, or 2 at each visit [Time Frame: up to approximately 56 weeks] 15. Proportion of particip	—

Measure

Time frame

1. Proportion of participants with Serious Treatment-Emergent Adverse Events (TEAEs) [Time Frame: up to approximately 56 weeks] 2. Proportion of participants with TEAEs leading to study drug discontinuation [Time Frame: up to approximately 56 weeks] 3. Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR) [Time Frame: up to approximately 56 weeks] 4. Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) [Time Frame: up to approximately 56 weeks] 5. Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) [Time Frame: up to approximately 56 weeks] 6. Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 100 (HiSCR100) [Time Frame: up to approximately 56 weeks] 7. Proportion of participants with flare at each visit [Time Frame: up to approximately 56 weeks] 8. Time to first flare [Time Frame: up to approximately 56 weeks] 9. Mean change from baseline of parent study in Hidradenitis Suppurativa Quality of Life (HiSQoL) score at each visit [Time Frame: up to approximately 56 weeks] 10. Mean change from baseline of parent study in Dermatology Life Quality Index (DLQI) score at each visit [Time Frame: up to approximately 56 weeks] 11. Proportion of participants with no increase in abscess and inflammatory nodule (AN) count relative to Week 54 at each visit [Time Frame: up to approximately 56 weeks] 12. Proportion of participants with no increase in abscess, inflammatory nodule, and draining tunnel (ANdT) count relative to Week 54 at each visit [Time Frame: up to approximately 56 weeks] 13. Proportion of participants with no increase in draining tunnel count relative to Week 54 at each visit [Time Frame: up to approximately 56 weeks] 14. Proportion of participants with a total AN count of 0, 1, or 2 at each visit [Time Frame: up to approximately 56 weeks] 15. Proportion of particip

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Countries

Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Greece, Italy, Japan, Netherlands, Poland, Spain, United Kingdom, United States

Contacts

Public ContactMedical Information Center

Incyte Biosciences Japan G.K.

jpmedinfo@incyte.com+81-120-094-139

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026